Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery

Conditions

Pigmentary Dispersion Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma

Keywords

Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary dispersion glaucoma, PDG, Hydrus

Brief summary

This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.

Detailed description

This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.

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Interventions

DEVICEHydrus Microstent

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

DEVICEiStent Trabecular Micro Bypass

Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

PROCEDURECataract removal and intraocular lens (IOL) implantation

Cataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG) * An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.

Exclusion criteria

* Forms of primary or secondary glaucoma not listed above * Prior glaucoma surgery in the study eye

Design outcomes

Primary

Measure	Time frame	Description
Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12	Month 12: 8 am, 12 pm, 4 pm	Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Secondary

Measure	Time frame	Description
Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12	Month 12: 8 am, 12 pm, and 4 pm	Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.
Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12	Month 12: 8 am, 12 pm, 4 pm	Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Participant flow

Recruitment details

Patients were screened and enrolled at 13 investigational sites outside of the United States

Pre-assignment details

This reporting group includes all randomized patients (306).

Participants by arm

Arm	Count
Hydrus Microstent Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)	154
iStent Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)	152
Total	306

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Discontinued	5	4
Overall Study	Lost to Follow-up	4	7
Overall Study	Missed Visits	1	0

Baseline characteristics

Characteristic	Hydrus Microstent	iStent	Total
Age, Continuous	72.5 years STANDARD_DEVIATION 7.2	71.5 years STANDARD_DEVIATION 7.5	72.0 years STANDARD_DEVIATION 7.3
Race/Ethnicity, Customized Asian	21 Participants	21 Participants	42 Participants
Race/Ethnicity, Customized Black or African Descent	4 Participants	3 Participants	7 Participants
Race/Ethnicity, Customized Caucasian/White European	103 Participants	106 Participants	209 Participants
Race/Ethnicity, Customized Hispanic/Latino/Central & South	24 Participants	22 Participants	46 Participants
Race/Ethnicity, Customized Native North American	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Other	1 Participants	0 Participants	1 Participants
Sex: Female, Male Female	86 Participants	71 Participants	157 Participants
Sex: Female, Male Male	68 Participants	81 Participants	149 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	4 / 154	3 / 152
other Total, other adverse events	24 / 154	16 / 152
serious Total, serious adverse events	2 / 154	8 / 152